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Pregnancy Safety Study Workshop Planned

[ Price : $8.95]

FDA and Duke-Margolis Center for Health Policy announce a 9/18-19 two-day public workshop to discuss pregnancy safety studies.

FDA Seeks Industry Help with Vaccine Panel

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Federal Register notice: FDA seeks participation by industry organizations in selecting nonvoting industry representatives to serv...

IRB Review Guide for Expanded Access

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Institutional Review Board (IRB) Review of Individual Patie...

Guide on Peptide Clin-Pharm Considerations

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for Peptide Drug Produ...

CMC Readiness Pilot Program

[ Price : $8.95]

Federal Register notice: FDA announces an opportunity to participate in its Chemistry, Manufacturing, and Controls (CMC) Developme...

S4 De Novo Authorization for esolution

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FDA grants S4 Medical a de novo authorization to market its esolution esophageal deviation device.

Novartis Recalls Sandimmune Lot

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Novartis recalls one lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/ml due to crystal formation obs...

FDA Updates Alert on Halyard N95 Masks

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FDA provides further clarification about a safety alert issued earlier this year that recommended against the use of certain surgi...

Endogenous Cushings Syndrome Guidance

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Federal Register notice: FDA makes available a draft guidance entitled Endogenous Cushings Syndrome: Developing Drugs for Treatmen...

Guide on ISO 10993-1 Biological Evaluations

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Federal Register notice: FDA posts a final guidance entitled Use of International Standard ISO 109931, Biological Evaluation of Me...